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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95946

30 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 03, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sklar Instruments

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

30 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 30

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning

Z-0925-2025
Recall number
Z-0925-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
25 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2273, UDI/DI 50649111448735, Lot Codes: SK-129; 2) 96-2283, UDI/DI 50649111448780, Lot Codes: SK-129

Distribution pattern

Domestic: Nationwide Distribution

device · product 2 of 30

ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)

Z-0926-2025
Recall number
Z-0926-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
125 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2483, UDI/DI 50649111449053, Lot codes: FSS5; 2) 96-2484, UDI/DI 50649111492950, Lot codes: SK-115

Distribution pattern

Domestic: Nationwide Distribution

device · product 3 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

Z-0927-2025
Recall number
Z-0927-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

941-0191, UDI/DI 50649111232730. Lot codes: 9249410191

Distribution pattern

Domestic: Nationwide Distribution

device · product 4 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)

Z-0928-2025
Recall number
Z-0928-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-2478, UDI/DI 50649111492615, Lot codes: SK-121

Distribution pattern

Domestic: Nationwide Distribution

device · product 5 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor

Z-0929-2025
Recall number
Z-0929-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
75 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2201A, UDI/DI 50649111493100, Lot Codes: SK-120; 2) 96-2203A, UDI/DI 50649111493094, Lot Codes: SK-120; 3) 96-2207A, UDI/DI 50649111493117, Lot Codes: SK-120; 4) 96-2208A, UDI/DI 50649111493124, Lot Codes: SK-120 5) 96-2209A, UDI/DI 50649111493155, Lot Codes: SK-120; 6) 96-2210A, UDI/DI 50649111493162, Lot Codes: SK-130; 7) 96-2241A, UDI/DI 50649111492820, Lot Codes: SK-115; 8) 96-2242A, UDI/DI 50649111492837, Lot Codes: SK-115;

Distribution pattern

Domestic: Nationwide Distribution

device · product 6 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal procedures

Z-0930-2025
Recall number
Z-0930-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
175 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2236, UDI/DI 50649111439757, Lot codes: SK-129, SK-130, SK-131; 2) 96-2237M, UDI/DI 50649111439764, Lot codes: SK-133; 3) 96-2238, UDI/DI 50649111439771, Lot codes: SK-131.

Distribution pattern

Domestic: Nationwide Distribution

device · product 7 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

Z-0931-2025
Recall number
Z-0931-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

941-1320, UDI/DI 50649111469907, Lot codes: 7249411320

Distribution pattern

Domestic: Nationwide Distribution

device · product 8 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STERILE NAIL NIPPER FLD SPRG 4.5STER25, Model Number 96-2666A; 5) ECONO STERILE NAIL NIPPER 4 1/2" STERILE 50, Model Number 96-2667; 6) ECONO STERILE NAIL NIPPER BRL SPRG 5.5STER25, Model Number 96-2671A; nail procedures

Z-0932-2025
Recall number
Z-0932-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
7730 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2424A, UDI/DI 50649111484504, Lot codes: SK-112; 2) 96-2427, UDI/DI 50649111449008, Lot codes: SK-131; 3) 96-2666, UDI/DI 50649111078918, Lot codes: SK-118; 4) 96-2666A, UDI/DI 50649111488120, Lot codes: SK-112, SK-118; 5) 96-2667, UDI/DI 50649111079090, Lot codes: SK-118; 6) 96-2671A, UDI/DI 50649111488113, Lot codes: SK-112.

Distribution pattern

Domestic: Nationwide Distribution

device · product 9 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors

Z-0933-2025
Recall number
Z-0933-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
1050 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2243, UDI/DI 50649111493087Lot codes: SK-115, SK-116, SK-129; 2) 96-2243M, UDI/DI 50649111448605Lot codes: SK-129; 3) 96-2267, UDI/DI 50649111448698Lot codes: SK-117; 4) 96-2267A, UDI/DI 50649111487604Lot codes: SK-112; 5) 96-2269A, UDI/DI 50649111487611Lot codes: SK-112; 6) 96-2959, UDI/DI 50649111493070Lot codes: SK-118.

Distribution pattern

Domestic: Nationwide Distribution

device · product 10 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental

Z-0934-2025
Recall number
Z-0934-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
25 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-2245M, UDI/DI 50649111448612, Lot codes: 0724962245M

Distribution pattern

Domestic: Nationwide Distribution

device · product 11 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous procedures

Z-0935-2025
Recall number
Z-0935-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
1050 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-4020M, UDI/DI 50649111476356, Lot codes: SK-125; 2) 96-4021M, UDI/DI 50649111476363, Lot codes: SK-125, SK-128; 3) 96-4022M, UDI/DI 50649111476370, Lot codes: SK-125.

Distribution pattern

Domestic: Nationwide Distribution

device · product 12 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips

Z-0936-2025
Recall number
Z-0936-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
300 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2630, UDI/DI 50649111072350, Lot codes: SK-128, SK-129; 2) 96-2636, UDI/DI 50649111073524, Lot codes: FSF14.

Distribution pattern

Domestic: Nationwide Distribution

device · product 13 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M

Z-0937-2025
Recall number
Z-0937-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
150 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-3500M, UDI/DI 50649111149960, Lot codes: SK-125

Distribution pattern

Domestic: Nationwide Distribution

device · product 14 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

Z-0938-2025
Recall number
Z-0938-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
150 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-4176, UDI/DI 50649111493674, Lot codes: FSS4, FSS5; 2) 96-4177, UDI/DI 50649111493681, Lot codes: FSS4, FSS5; 3) 96-5434, UDI/DI 50649111493612, Lot codes: FSS4, FSS5; 4) 96-5435, UDI/DI 50649111493629, Lot codes: FSS4, FSS5, FSS6; 5) 96-5436, UDI/DI 50649111493636, Lot codes: FSS4, FSS5; 6) 96-5437, UDI/DI 50649111493643, Lot codes: FSS4, FSS5; 7) 96-5438, UDI/DI 50649111493650, Lot codes: FSS4, FSS5; 8) 96-5439, UDI/DI 50649111493667, Lot codes: FSS4, FSS5; 9) 96-5440, UDI/DI 50649111493964, Lot codes: FSS4, FSS5; 10) 96-5492, UDI/DI 50649111481657, Lot codes: FSS4, FSS5; 11) 96-5493, UDI/DI 50649111481664, Lot codes: FSS4, FSS5; 12) 96-5494, UDI/DI 50649111481671, Lot codes: FSS4, FSS5.

Distribution pattern

Domestic: Nationwide Distribution

device · product 15 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25 C25,Model Number 941-0691; 5) ECONO STERILE IRIS FCP SERR 4.25 STER CS100,Model Number 941-1414; 6) ECONO STERILE PEDIATRIC MAGILL CATH FCP CS25,Model Number 94-1924; 7) ECONO STERILE STRL ALLIGATOR FCPS 3.5" 25/CS,Model Number 94-5034; 8) ECONO STERILE SERR DRESSING FCP 5 1/2" CS/50,Model Number 94-6146; 9) ECONO STERILE KELLY RANKIN FCP CVD 6.25 CS25,Model Number 94-6616; 10) ECONO STERILE JANSEN NSL FCP BY6.5 STRLCS/25,Model Number 96-2215A; 11) ECONO STERILE BALLENGR SPNG FCP SERR7"CS/25,Model Number 96-2289; 12) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293; 13) ECONO STERILE LUCAE BAYONET FCP SERR5.5CS/25,Model Number 96-2293A; 14) ECONO STERILE RUSSIAN TISSUE FCP 6" STER25,Model Number 96-2295A; 15) ECONO STERILE TISSUE FCP 1X2 8" STRL CS/25,Model Number 96-2351; 16) ECONO STERILE SCHROEDER BRAUN TEN FCP10CS/25,Model Number 96-2386; 17) ECONO STERILE TUBE OCCL FCP SM STR 7"STER 50,Model Number 96-2406; 18) ECONO STERILE TUBE OCC FCP SM STR 7" STER 25,Model Number 96-2408; 19) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 50,Model Number 96-2410; 20) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412; 21) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412A; 22) ECONO STERILE FN-PT SPLINT FCP 4 1/2 STER 25,Model Number 96-2412M; 23) ECONO STERILE SEMKEN DRESS FCP SERR 5"STER25,Model Number 96-2450M; 24) ECONO STERILE RANKIN KELLY FCP STR6.25 CS/25,Model Number 96-2461; 25) ECONO STERILE RANKIN KELLY FCP CVD6.25 CS/25,Model Number 96-2462; 26) ECONO STERILE IRIS FCP X-FINE ANG 3.5 STER25,Model Number 96-2470A; 27) ECONO STERILE IRIS FCP X-FINE STR 3.5 STER25,Model Number 96-2472A; 28) ECONO STERILE IRIS FCP 1/2CVD SERR STER CS25,Model Number 96-2515; 29) ECONO STERILE IRIS FCP 1/2CVD 1x2 STER CS25,Model Number 96-2515A; 30) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER50,Model Number 96-2532; 31) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533; 32) ECONO STERILE FOERSTER SPONGE FCP 9.5 STER25,Model Number 96-2533A; 33) ECONO STERILE SPONGE FCP STR SERR 9.5 STER25,Model Number 96-2533M; 34) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534; 35) ECONO STERILE FOERSTER SPG FCP CVD 9.5STER25,Model Number 96-2534A; 36) ECONO STERILE IRIS FCP STR 1X2 4" STER CS/25,Model Number 96-2535A; 37) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536; 38) ECONO STERILE HALSTED FCP STR 5" STER CS/50,Model Number 96-2536M; 39) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537; 40) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537A; 41) ECONO STERILE HALSTED FCP STR 5" STER CS/25,Model Number 96-2537M; 42) ECONO STERILE HALSTED FCP CVD 5" STER CS/50,Model Number 96-2538; 43) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539; 44) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539A; 45) ECONO STERILE HALSTED FCP CVD 5" STER CS/25,Model Number 96-2539M; 46) ECONO STERILE ROCH PEAN FCP STR STER 61/4 50,Model Number 96-2544; 47) ECONO STERILE ROCH PEAN FCP STR STER 61/4 25,Model Number 96-2545; 48) ECONO STERILE ROCH PEAN CVD 6 1/4 STERL CS25,Model Number 96-2547; 49) ECONO STERILE ROCH PEAN CVD 6 1/4 STER CS/25,Model Number 96-2547A; 50) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 25,Model Number 96-2548; 51) ECONO STERILE ROCH-PEAN FCP CVD 8.5" STER 50,Model Number 96-2549; 52) ECONO STERILE CRILE FCP STR 5.5" STERL CS/50,Model Number 96-2550; 53) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551; 54) ECONO STERILE CRILE FCP STR 5.5" STERL CS/25,Model Number 96-2551A;

Z-0939-2025
Recall number
Z-0939-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
245015 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 94-0286, UDI/DI 50649111094406, Lot codes: FSF21; 2) 94-0290, UDI/DI 50649111095045, Lot codes: SK-115; 3) 94-0291, UDI/DI 50649111095144, Lot codes: 824940291, 924940291; 4) 941-0691, UDI/DI 50649111307902, Lot codes: MST8, MST9; 5) 941-1414, UDI/DI 50649111464872, Lot codes: SK-122; 6) 94-1924, UDI/DI 50649111345775, Lot codes: FSF16, FSF22; 7) 94-5034, UDI/DI 50649111040687, Lot codes: SK-112, SK-135; 8) 94-6146, UDI/DI 50649111215535, Lot codes: SK-135; 9) 94-6616, UDI/DI 50649111287457, Lot codes: SK-132; 10) 96-2215A, UDI/DI 50649111487567, Lot codes: HSI; 11) 96-2289, UDI/DI 50649111439986, Lot codes: SK-116; 12) 96-2293, UDI/DI 50649111440012, Lot codes: SK-115, SK-132; 13) 96-2293A, UDI/DI 50649111487598, Lot codes: HSI; 14) 96-2295A, UDI/DI 50649111493254, Lot codes: HST21; 15) 96-2351, UDI/DI 50649111440081, Lot codes: FST21; 16) 96-2386, UDI/DI 50649111440241, Lot codes: FSF18; 17) 96-2406, UDI/DI 50649111035195, Lot codes: FSF18, FSF24, FSF25; 18) 96-2408, UDI/DI 50649111035355, Lot codes: FSF5, FSF12, FSF18, FSF26; 19) 96-2410, UDI/DI 50649111035669, Lot codes: FST9; 20) 96-2412, UDI/DI 50649111035867, Lot codes: FST6, FST9, FST10, FST11, FST12, FST20; 21) 96-2412A, UDI/DI 50649111487550, Lot codes: SK-112; 22) 96-2412M, UDI/DI 50649111027015, Lot codes: 0724962412M; 23) 96-2450M, UDI/DI 50649111464483, Lot codes: 0624962450M; 24) 96-2461, UDI/DI 50649111440432, Lot codes: SK-132; 25) 96-2462, UDI/DI 50649111464490, Lot codes: SK-132; 26) 96-2470A, UDI/DI 50649111487970, Lot codes: SK-112; 27) 96-2472A, UDI/DI 50649111487987, Lot codes: SK-112; 28) 96-2515, UDI/DI 50649111050235, Lot codes: SK-115; 29) 96-2515A, UDI/DI 50649111487857, Lot codes: SK-112; 30) 96-2532, UDI/DI 50649111053212, Lot codes: FSF8, FSF14; 31) 96-2533, UDI/DI 50649111053397, Lot codes: FSF8, FSF11, FSF14, FSF16, FSF17, FSF20, FSF21, FSF22, FSF23; 32) 96-2533A, UDI/DI 50649111487888, Lot codes: HSI; 33) 96-2533M, UDI/DI 50649111215313, Lot codes: SK-116; 34) 96-2534, UDI/DI 50649111478817, Lot codes: FSF15, FSF21, FSF22, FSF23; 35) 96-2534A, UDI/DI 50649111492653, Lot codes: HSF8, HSF18; 36) 96-2535A, UDI/DI 50649111488304, Lot codes: SK-112; 37) 96-2536, UDI/DI 50649111054172, Lot codes: FSF10, FSF21; 38) 96-2536M, UDI/DI 50649111220034, Lot codes: 0724962536M; 39) 96-2537, UDI/DI 50649111054424, Lot codes: FSF5, FSF10; 40) 96-2537A, UDI/DI 50649111219496, Lot codes: SK-112; 41) 96-2537M, UDI/DI 50649111221758, Lot codes: 0724962537M; 42) 96-2538, UDI/DI 50649111054639, Lot codes: FSF10, FSF14, FSF18, FSF20, FSF21, FSF22, FSF23; 43) 96-2539, UDI/DI 50649111054783, Lot codes: FSF5, FSF6, FSF10, FSF12, FSF13, FSF14, FSF18, FSF21, FSF22, FSF24; 44) 96-2539A, UDI/DI 50649111487901, Lot codes: SK-112; 45) 96-2539M, UDI/DI 50649111225336, Lot codes: 0724962539M; 46) 96-2544, UDI/DI 50649111056008, Lot codes: FSF8, FSF10; 47) 96-2545, UDI/DI 50649111056183, Lot codes: FSF10, FSF21; 48) 96-2547, UDI/DI 50649111056497, Lot codes: FSF8, FSF10, FSF13, FSF20, FSF21, FSF22, FSF24, FSF26; 49) 96-2547A, UDI/DI 50649111236417, Lot codes: SK-112, SK-136; 50) 96-2548, UDI/DI 50649111056725, Lot codes: FSF12; 51) 96-2549, UDI/DI 50649111056800, Lot codes: FSF8, FSF17, FSF26; 52) 96-2550, UDI/DI 50649111057135, Lot codes: FSF9, FSF19, FSF22, FSF24; 53) 96-2551, UDI/DI 50649111057234, Lot codes: FSF9, FSF20, FSF24, FSF25; 54) 96-2551A, UDI/DI 50649111487819, Lot codes: SK-112; 55) 96-2552, UDI/DI 50649111057579, Lot codes: FSF13, FSF14, FSF16, FSF21, FSF24; 56) 96-2552M, UDI/DI 50649111400818, Lot codes: SK-133; 57) 96-2553, UDI/DI 50649111057715, Lot codes: FSF5; 58) 96-2554, UDI/DI 50649111057814, Lot codes: SK-134; 59) 96-2555, UDI/DI 50649111057982, Lot codes: FSF19, FSF20, FSF26; 60) 96-2556, UDI/DI 50649111058248, Lot codes: SK-131; 61) 96-2557, UDI/DI 50649111058545, Lot codes: FSF19, FSF26; 62) 96-2558, UDI/DI 50649111058644, Lot codes: SK-131; 63) 96-2559, UDI/DI 50649111058903, Lot codes: SK-115; 64) 96-2559A, UDI/DI 50649111487635, Lot codes: SK-112; 65) 96-2560, UDI/DI 50649111059078, Lot codes: FSF13, FSF14, FSF19, FSF20, FSF21, FSF22, FSF24, FSF25, FSF26; 66) 96-2561, UDI/DI 50649111059290, Lot codes: FSF5, FSF7, FSF8, FSF9, FSF19, FSF20, FSF22, FSF24; 67) 96-2561A, UDI/DI 50649111488007, Lot codes: SK-112; 68) 96-2561M, UDI/DI 50649111259041, Lot codes: 0724962561M; 69) 96-2562, UDI/DI 50649111059511, Lot codes: FSF7, FSF8, FSF11, FSF12, FSF18, FSF19, FSF21, FSF22, FSF26; 70) 96-2563, UDI/DI 50649111059733, Lot codes: FSF5, FSF9, FSF12, FSF14, FSF17, FSF21, FSF22, FSF24; 71) 96-2563A, UDI/DI 50649111487994, Lot codes: SK-112; 72) 96-2563M, UDI/DI 50649111262218, Lot codes: 0724962563M; 73) 96-2566A, UDI/DI 50649111488175, Lot codes: SK-112; 74) 96-2568, UDI/DI 50649111060531, Lot codes: FST13, FST21; 75) 96-2568A, UDI/DI 50649111267558, Lot codes: SK-115; 76) 96-2569, UDI/DI 50649111060715, Lot codes: FST9, FST10, FST21; 77) 96-2569A, UDI/DI 50649111487840, Lot codes: HSI; 78) 96-2570, UDI/DI 50649111060845, Lot codes: SK-115; 79) 96-2570M, UDI/DI 50649111271821, Lot codes: SK-116; 80) 96-2571, UDI/DI 50649111061033, Lot codes: SK-115; 81) 96-2571A, UDI/DI 50649111487642, Lot codes: HSI; 82) 96-2571M, UDI/DI 50649111273498, Lot codes: SK-116; 83) 96-2572, UDI/DI 50649111061187, Lot codes: SK-115; 84) 96-2573, UDI/DI 50649111061408, Lot codes: SK-115, SK-130; 85) 96-2573A, UDI/DI 50649111487758, Lot codes: HSI; 86) 96-2573M, UDI/DI 50649111276697, Lot codes: SK-115, SK-116; 87) 96-2575, UDI/DI 50649111061644, Lot codes: FSF9; 88) 96-2575A, UDI/DI 50649111487789, Lot codes: SK-112; 89) 96-2576, UDI/DI 50649111061897, Lot codes: FSF9; 90) 96-2578, UDI/DI 50649111062375, Lot codes: 724962578; 91) 96-2579, UDI/DI 50649111062542, Lot codes: 724962579; 92) 96-2579M, UDI/DI 50649111285576, Lot codes: 0724962579M; 93) 96-2588, UDI/DI 50649111064096, Lot codes: SK-115; 94) 96-2620, UDI/DI 50649111070493, Lot codes: SK-130; 95) 96-2622, UDI/DI 50649111070851, Lot codes: SK-130, SK-131; 96) 96-2622A, UDI/DI 50649111487802, Lot codes: SK-112; 97) 96-2623A, UDI/DI 50649111488205, Lot codes: SK-112, SK-134; 98) 96-2624, UDI/DI 50649111071209, Lot codes: FSF12, FSF17, FSF18, FSF19, FSF20, FSF22, FSF23, FSF24, FSF25; 99) 96-2624A, UDI/DI 50649111488212, Lot codes: SK-112; 100) 96-2626, UDI/DI 50649111071476, Lot codes: FSF15, FSF22; 101) 96-2653, UDI/DI 50649111076525, Lot codes: FSF8, FSF9, FSF18, FSF20, FSF24; 102) 96-2655, UDI/DI 50649111077027, Lot codes: SK-115; 103) 96-2656, UDI/DI 50649111077072, Lot codes: SK-115; 104) 96-2657, UDI/DI 50649111077232, Lot codes: FSF8, FSF10; 105) 96-2658, UDI/DI 50649111077461, Lot codes: FSF10, FSF17, FSF18, FSF24; 106) 96-2660, UDI/DI 50649111077928, Lot codes: FST10, FST13; 107) 96-2661, UDI/DI 50649111078024, Lot codes: 724962661; 108) 96-2670, UDI/DI 50649111079588, Lot codes: SK-115; 109) 96-2670M, UDI/DI 50649111034556, Lot codes: 0724962670M; 110) 96-2684, UDI/DI 50649111081703, Lot codes: SK-116; 111) 96-2685, UDI/DI 50649111081857, Lot codes: SK-116; 112) 96-2685A, UDI/DI 50649111488038, Lot codes: 60359; 113) 96-2687A, UDI/DI 50649111488311, Lot codes: 60431; 114) 96-2688, UDI/DI 50649111082335, Lot codes: SK-115; 115) 96-2689, UDI/DI 50649111082472, Lot codes: SK-116; 116) 96-2706, UDI/DI 50649111084995, Lot codes: SK-130; 117) 96-2736A, UDI/DI 50649111487918, Lot codes: SK-112; 118) 96-2737A, UDI/DI 50649111488106, Lot codes: SK-112; 119) 96-2738A, UDI/DI 50649111487956, Lot codes: SK-112; 120) 96-2739A, UDI/DI 50649111487963, Lot codes: SK-112, SK-133; 121) 96-2764A, UDI/DI 50649111487871, Lot codes: SK-112; 122) 96-2765, UDI/DI 50649111094185, Lot codes: FST16; 123) 96-2772A, UDI/DI 50649111492585, Lot codes: HSF26; 124) 96-2773A, UDI/DI 50649111492592, Lot codes: SK-133, SK-134; 125) 96-2775, UDI/DI 50649111095793, Lot codes: SK-115; 126) 96-2776A, UDI/DI 50649111492981, Lot codes: SK-115; 127) 96-2777A, UDI/DI 50649111492974, Lot codes: SK-115; 128) 96-2779A, UDI/DI 50649111492967, Lot codes: SK-115; 129) 96-2785A, UDI/DI 50649111488076, Lot codes: HSI; 130) 96-2786A, UDI/DI 50649111488083, Lot codes: HSI; 131) 96-2787A, UDI/DI 50649111488090, Lot codes: HSI; 132) 96-2790A, UDI/DI 50649111488250, Lot codes: SK-112; 133) 96-2791A, UDI/DI 50649111488267, Lot codes: SK-112; 134) 96-2795, UDI/DI 50649111488366, Lot codes: FSF21, FSF24; 135) 96-2921, UDI/DI 50649111120525, Lot codes: FST9; 136) 96-2921A, UDI/DI 50649111480865, Lot codes: HSI; 137) 96-3006, UDI/DI 50649111134720, Lot codes: FSF8, FSF9, FSF26; 138) 96-3010, UDI/DI 50649111135482, Lot codes: FSF21; 139) 96-3015A, UDI/DI 50649111488182, Lot codes: SK-112; 140) 96-3016A, UDI/DI 50649111488199, Lot codes: SK-112; 141) 96-3020A, UDI/DI 50649111493179, Lot codes: HST12; 142) 96-3023A, UDI/DI 50649111493209, Lot codes: HST7; 143) 96-3025A, UDI/DI 50649111493223, Lot codes: HST12; 144) 96-3030A, UDI/DI 50649111492998, Lot codes: SK-134; 145) 96-3558A, UDI/DI 50649111487772, Lot codes: SK-112; 146) 96-3560, UDI/DI 50649111440890, Lot codes: SK-112, SK-131, SK-132; 147) 96-3560A, UDI/DI 50649111487765, Lot codes: SK-112; 148) 96-3566A, UDI/DI 50649111492691, Lot codes: SK-116; 149) 96-3615, UDI/DI 50649111449701, Lot codes: FST10.

Distribution pattern

Domestic: Nationwide Distribution

device · product 16 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A

Z-0940-2025
Recall number
Z-0940-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-4921A, UDI/DI 50649111493278, Lot codes: FSF20

Distribution pattern

Domestic: Nationwide Distribution

device · product 17 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; 17) ECONO STERILE MAYO DISS SCISS CV 9"STRLCS/25,Model Number 96-2261; 18) ECONO STERILE MAYO DISS SCISS CVD 9" STER25,Model Number 96-2261A; 19) ECONO STERILE METZENBAUM SCIS STR7"STRLCS/25,Model Number 96-2263A; 20) ECONO STERILE METZENBAUM SCIS STR9"STER CS25,Model Number 96-2266; 21) ECONO STERILE MAYO DISS SCISS CVD 5.5"CS/25,Model Number 96-2433; 22) ECONO STERILE MAYO DISS SCISS CVD 6.75"CS/25,Model Number 96-2435; 23) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437; 24) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437A; 25) ECONO STERILE IRIS SCISS CVD S/S 3.5" CS/25,Model Number 96-2471; 26) ECONO STERILE TOENAIL SCISS CVD 4.5" STER 25,Model Number 96-2492A; 27) ECONO STERILE IRIS SCIS CVD DEL 4 STER CS/25,Model Number 96-2494A; 28) ECONO STERILE IRIS SCIS STR LG RG 4.5 STER25,Model Number 96-2495A; 29) ECONO STERILE IRIS SCISS STR S/S 3.5" CS/25,Model Number 96-2496; 30) ECONO STERILE IRIS SCIS STR S/S 3.5 STER C50,Model Number 96-2497; 31) ECONO STERILE IRIS SCIS CVD S/S 3.5 STER C50,Model Number 96-2499; 32) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500; 33) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500A; 34) ECONO STERILE LISTER BAND SCISS 5.5 STER C50,Model Number 96-2502; 35) ECONO STERILE LISTER BAND SCIS STER 5 1/2 50,Model Number 96-2502M; 36) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503; 37) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503A; 38) ECONO STERILE IRIS SCIS STR S/S 4.5 STER C50,Model Number 96-2504; 39) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505; 40) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505A; 41) ECONO STERILE IRIS SCIS CVD S/S 4.5 STER C50,Model Number 96-2506; 42) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/50,Model Number 96-2506M; 43) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507; 44) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507A; 45) ECONO STERILE SPENCER ST SCIS DEL 3.5 STER25,Model Number 96-2511A; 46) ECONO STERILE LITT SUT SCIS 5 1/2 STER CS/50,Model Number 96-2512; 47) ECONO STERILE LITT SUT SCISS 5 1/2 STER CS25,Model Number 96-2513; 48) ECONO STERILE OR SCIS STR B/B 5.5" STER CS50,Model Number 96-2514; 49) ECONO STERILE METZ SCISS STR STER 5.5" CS/50,Model Number 96-2516; 50) ECONO STERILE METZ SCISS STR STER 5.5" 25/CS,Model Number 96-2517; 51) ECONO STERILE METZ SCISS STRS 5.5" STER CS25,Model Number 96-2517A; 52) ECONO STERILE WIRE CUT SCIS ANG 4 3/4 STRL25,Model Number 96-2519; 53) ECONO STERILE OR SCISS STR S/B 5.5" STER C50,Model Number 96-2520; 54) ECONO STERILE OR SCIS STR S/B 5.5 STER CS50,Model Number 96-2520A;

Z-0941-2025
Recall number
Z-0941-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
252865 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 941-0918, UDI/DI 50649111344174, Lot codes MSS8; 2) 941-1556, UDI/DI 50649111447752, Lot codes FSS19, FSS23; 3) 941-1613, UDI/DI 50649111447912, Lot codes FSS17; 4) 94-1346, UDI/DI 50649111256613, Lot codes FSS8; 5) 94-1925, UDI/DI 50649111345966, Lot codes FSS10, FSS17, FSS20; 6) 94-4091, UDI/DI 50649111288454, Lot codes FSK12; 7) 94-5692, UDI/DI 50649111150126, Lot codes FSS20; 8) 94-6096, UDI/DI 50649111207509, Lot codes FSS5, FSS10, FSS17; 9) 94-6097, UDI/DI 50649111207622, Lot codes FSS26; 10) 96-1220, UDI/DI 50649111246096, Lot codes 724961220; 11) 96-1221, UDI/DI 50649111246140, Lot codes 824961221; 12) 96-1222, UDI/DI 50649111246287, Lot codes 724961222; 13) 96-1224, UDI/DI 50649111246546, Lot codes 724961224; 14) 96-1226, UDI/DI 50649111246867, Lot codes 724961226; 15) 96-1228, UDI/DI 50649111247178, Lot codes 824961228; 16) 96-2260, UDI/DI 50649111492622, Lot codes FSS17, FSS21; 17) 96-2261, UDI/DI 50649111439870, Lot codes FSS5; 18) 96-2261A, UDI/DI 50649111492646, Lot codes HSS23; 19) 96-2263A, UDI/DI 50649111487536, Lot codes SK-112; 20) 96-2266, UDI/DI 50649111488359, Lot codes FSS23; 21) 96-2433, UDI/DI 50649111440357, Lot codes FSS5; 22) 96-2435, UDI/DI 50649111440371, Lot codes FSS8; 23) 96-2437, UDI/DI 50649111440395, Lot codes FSS17, FSF21, FSS24; 24) 96-2437A, UDI/DI 50649111487543, Lot codes HSI; 25) 96-2471, UDI/DI 50649111440524, Lot codes 724962471; 26) 96-2492A, UDI/DI 50649111493933, Lot codes 0824962492A; 27) 96-2494A, UDI/DI 50649111488229, Lot codes HSI; 28) 96-2495A, UDI/DI 50649111488236, Lot codes HSI; 29) 96-2496, UDI/DI 50649111440630, Lot codes SK-127; 30) 96-2497, UDI/DI 50649111046924, Lot codes SK-127; 31) 96-2499, UDI/DI 50649111047341, Lot codes 824962499; 32) 96-2500, UDI/DI 50649111047617, Lot codes FSS7, FSS10, FSS26; 33) 96-2500A, UDI/DI 50649111487581, Lot codes HSI; 34) 96-2502, UDI/DI 50649111048041, Lot codes FSS7, FSS9, FSS10, FSS11, FSS15, FSS16, FSS19, FSS20; 35) 96-2502M, UDI/DI 50649111169289, Lot codes SK-133; 36) 96-2503, UDI/DI 50649111048225, Lot codes FSS5, FSS11, FSS15, FSS22; 37) 96-2503A, UDI/DI 50649111487574, Lot codes HSI; 38) 96-2504, UDI/DI 50649111048386, Lot codes FSS7, FSS8, FSS16, FSS17, FSS23, FSS26; 39) 96-2505, UDI/DI 50649111048577, Lot codes FSS5, FSS6; 40) 96-2505A, UDI/DI 50649111487628, Lot codes HSI; 41) 96-2506, UDI/DI 50649111048799, Lot codes SK-127; 42) 96-2506M, UDI/DI 50649111174535, Lot codes MSS8; 43) 96-2507, UDI/DI 50649111049017, Lot codes SK-124, SK-127; 44) 96-2507A, UDI/DI 50649111488243, Lot codes HSI; 45) 96-2511A, UDI/DI 50649111480704, Lot codes 60577; 46) 96-2512, UDI/DI 50649111049819, Lot codes FSS13, FSS15, FSS17, FSS19, FSS24; 47) 96-2513, UDI/DI 50649111050006, Lot codes FSS15; 48) 96-2514, UDI/DI 50649111050129, Lot codes FSS8; 49) 96-2516, UDI/DI 50649111050402, Lot codes SK-130; 50) 96-2517, UDI/DI 50649111050594, Lot codes SK-130; 51) 96-2517A, UDI/DI 50649111487680, Lot codes SK-112; 52) 96-2519, UDI/DI 50649111050976, Lot codes SK-126; 53) 96-2520, UDI/DI 50649111051119, Lot codes FSS7, FSS8, FSS10, FSS11, FSS16, FSS23; 54) 96-2520A, UDI/DI 50649111194090, Lot codes FSS8, FSS20, HSS8, HSS9, HSS17, HSS19; 55) 96-2521, UDI/DI 50649111051256, Lot codes FSS5, FSS8, FSS10, FSS19, FSS20, FSS22, FSS23, FSS24; 56) 96-2521A, UDI/DI 50649111487659, Lot codes SK-112; 57) 96-2522, UDI/DI 50649111051416, Lot codes FSS8, FSS20, FSS23, FSS24, FSS26; 58) 96-2523, UDI/DI 50649111051584, Lot codes FSS7, FSS8, FSS10, FSS17, FSS19, FSS20, FSS22; 59) 96-2523A, UDI/DI 50649111487666, Lot codes SK-112; 60) 96-2523M, UDI/DI 50649111199880, Lot codes MSS10; 61) 96-2524, UDI/DI 50649111051638, Lot codes FSS26; 62) 96-2527, UDI/DI 50649111052215, Lot codes FSS26; 63) 96-2530, UDI/DI 50649111052802, Lot codes FSS6, FSS7, FSS10, FSS20, FSS22, FSS24; 64) 96-2531, UDI/DI 50649111053069, Lot codes FSS5; 65) 96-2531A, UDI/DI 50649111487673, Lot codes SK-112; 66) 96-2592, UDI/DI 50649111064911, Lot codes FSS13; 67) 96-2593, UDI/DI 50649111065031, Lot codes FSS13; 68) 96-2596, UDI/DI 50649111065826, Lot codes FSF26; 69) 96-2596M, UDI/DI 50649111311275, Lot codes SK-133; 70) 96-2597, UDI/DI 50649111065888, Lot codes FSS10, FSS21, FSS24; 71) 96-2598, UDI/DI 50649111066205, Lot codes FSS10, FSS24, FSS25; 72) 96-2640, UDI/DI 50649111074347, Lot codes FSS20; 73) 96-2649, UDI/DI 50649111075849, Lot codes FSS10, FSS12, FSS13, FSS15, FSS16, FSS18, FSS20, FSS21; 74) 96-2649G, UDI/DI 50649111005082, Lot codes FSS8, FSS10, FSS12, FSS13, FSS15, FSS16, FSS17, FSS20; 75) 96-2650, UDI/DI 50649111076198, Lot codes FSS8, FSS16, FSS17, FSS22, FSS23, FSS24, FSS26; 76) 96-2651, UDI/DI 50649111076266, Lot codes SK-127, SK-129; 77) 96-2654, UDI/DI 50649111076884, Lot codes FSS9, FSS10, FSS16, FSS19; 78) 96-2662, UDI/DI 50649111078246, Lot codes FSS13, FSS15; 79) 96-2673A, UDI/DI 50649111493056, Lot codes SK-134; 80) 96-2680, UDI/DI 50649111081109, Lot codes FSS20, FSS22, FSS26; 81) 96-2682, UDI/DI 50649111081499, Lot codes FSS10, FSS13, FSS21, FSS22, FSS26; 82) 96-2682A, UDI/DI 50649111487703, Lot codes SK-112; 83) 96-2683A, UDI/DI 50649111487710, Lot codes HSI; 84) 96-2690A, UDI/DI 50649111487727, Lot codes HSI; 85) 96-2691A, UDI/DI 50649111487734, Lot codes HSI; 86) 96-2703, UDI/DI 50649111084537, Lot codes 724962703; 87) 96-2704, UDI/DI 50649111084735, Lot codes 724962704; 88) 96-2720A, UDI/DI 50649111487697, Lot codes SK-112; 89) 96-2728, UDI/DI 50649111088221, Lot codes FSS10, FSS13, FSS24.

Distribution pattern

Domestic: Nationwide Distribution

device · product 18 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor

Z-0942-2025
Recall number
Z-0942-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
25 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-2395M, UDI/DI 50649111448896, Lot codes: SK-133

Distribution pattern

Domestic: Nationwide Distribution

device · product 19 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy

Z-0943-2025
Recall number
Z-0943-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-4113, UDI/DI 50649111492899, Lot codes: SK-133; 2) 96-4144A, UDI/DI 50649111492523, Lot codes: HSC21; 3) 96-4145A, UDI/DI 50649111492608, Lot codes: HSC21.

Distribution pattern

Domestic: Nationwide Distribution

device · product 20 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDERSON SPEC STERILE" SM BX/25, Model Number 96-2613; 5)ECONO STERILE PEDERSON SPEC STRL MD BX/25, Model Number 96-2615; 6) ECONO STERILE PEDERSON SPEC STRL LG BX/50, Model Number 96-2616; 7) ECONO STERILE PEDERSON SPEC STRL LG BX/25, Model Number 96-2617; 8) ECONO STERILE GRAVES VAG SPEC STRL MD CS/50, Model Number 96-3001; 9) ECONO STERILE GRAVES VAG SPEC STRL LG CS/50, Model Number 96-3002; speculum, gynecological

Z-0944-2025
Recall number
Z-0944-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
475 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2603, UDI/DI 50649111067233, Lot Codes: SK-119; 2) 96-2605, UDI/DI 50649111067622, Lot Codes: SK-119; 3) 96-2607, UDI/DI 50649111067967, Lot Codes: SK-119; 4) 96-2613, UDI/DI 50649111068964, Lot Codes: SK-119; 5) 96-2615, UDI/DI 50649111069343, Lot Codes: SK-119; 6) 96-2616, UDI/DI 50649111069572, Lot Codes: SK-119; 7) 96-2617, UDI/DI 50649111069886, Lot Codes: SK-119; 8) 96-3001, UDI/DI 50649111133884, Lot Codes: SK-119; 9) 96-3002, UDI/DI 50649111134058, Lot Codes: SK-119.

Distribution pattern

Domestic: Nationwide Distribution

device · product 21 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures

Z-0945-2025
Recall number
Z-0945-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
40 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-4142A, UDI/DI 50649111488014, Lot Codes: HSI

Distribution pattern

Domestic: Nationwide Distribution

device · product 22 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

Z-0946-2025
Recall number
Z-0946-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
75 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-0960, UDI/DI 50649111474796, Lot codes: FSS5; 2) 96-0961, UDI/DI 50649111474802, Lot codes: FSS5; 3) 96-0962, UDI/DI 50649111474819, Lot codes: FSS5; 4) 96-0963, UDI/DI 50649111474826, Lot codes: FSS5; 5) 96-0964, UDI/DI 50649111474833, Lot codes: FSS5; 6) 96-0965, UDI/DI 50649111474840, Lot codes: FSS5; 7) 96-0966, UDI/DI 50649111474857, Lot codes: SK-119.

Distribution pattern

Domestic: Nationwide Distribution

device · product 23 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy

Z-0947-2025
Recall number
Z-0947-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-4134M, UDI/DI 50649111492547, Lot codes: SK-114; 2) 96-4137M, UDI/DI 50649111492530, Lot codes: SK-116.

Distribution pattern

Domestic: Nationwide Distribution

device · product 24 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A

Z-0948-2025
Recall number
Z-0948-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-4146A, UDI/DI 50649111492707, Lot Codes: SK-136

Distribution pattern

Domestic: Nationwide Distribution

device · product 25 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery

Z-0949-2025
Recall number
Z-0949-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-3814, UDI/DI 50649111455986, Lot codes: 050824-01¿¿ ¿

Distribution pattern

Domestic: Nationwide Distribution

device · product 26 of 30

Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery

Z-0950-2025
Recall number
Z-0950-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
350 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2540, UDI/DI 50649111054967, Lot codes: FSS8, FSS10; 2) 96-2541, UDI/DI 50649111055087, Lot codes: FSS10; 3) 96-2542, UDI/DI 50649111055391, Lot codes: FSS10; 4) 96-2542M, UDI/DI 50649111440685, Lot codes: MSS10.

Distribution pattern

Domestic: Nationwide Distribution

device · product 27 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery

Z-0951-2025
Recall number
Z-0951-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
25 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-2224A, UDI/DI 50649111487932, Lot codes: HSI

Distribution pattern

Domestic: Nationwide Distribution

device · product 28 of 30

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery

Z-0952-2025
Recall number
Z-0952-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
0 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

96-4780A, UDI/DI 50649111488021, Lot codes: HSI

Distribution pattern

Domestic: Nationwide Distribution

device · product 29 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe

Z-0953-2025
Recall number
Z-0953-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
2500 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 94-5923, UDI/DI 50649111181663, Lot codes: SK-115, SK-116; 2) 96-2361, UDI/DI 50649111392601, Lot codes: SK-115.

Distribution pattern

Domestic: Nationwide Distribution

device · product 30 of 30

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery

Z-0954-2025
Recall number
Z-0954-2025
Initiated
December 03, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Sklar Instruments
Quantity
41850 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports of various packaging issues that may result in a breach of the sterile barrier.

Code information

1) 96-2352A, UDI/DI 50649111488151, Lot codes: HSI; 2) 96-2353, UDI/DI 50649111397996, Lot codes: SK-130; 3) 96-2355A, UDI/DI 50649111488144, Lot codes: HSI; 4) 96-2356A, UDI/DI 50649111488137, Lot codes: HSI; 5) 96-2358A, UDI/DI 50649111488168, Lot codes: HSI; 6) 96-2417, UDI/DI 50649111440272, Lot codes: SK-130; 7) 96-2580, UDI/DI 50649111062696, Lot codes: FSF12, FSF13, FSF17, FSF20, FSF22, FSF24, FSF26, FSS19; 8) 96-2581, UDI/DI 50649111062955, Lot codes: FSF12, FSF17, FSF20, FSF22; 9) 96-2581A, UDI/DI 50649111487796, Lot codes: SK-112; 10) 96-2583, UDI/DI 50649111063266, Lot codes: SK-130; 11) 96-2583A, UDI/DI 50649111487833, Lot codes: SK-112; 12) 96-2585, UDI/DI 50649111063549, Lot codes: FSF12, FSF14, FSF21; 13) 96-2585A, UDI/DI 50649111487895, Lot codes: SK-112; 14) 96-2586, UDI/DI 50649111063877, Lot codes: SK-130; 15) 96-2587, UDI/DI 50649111064010, Lot codes: SK-130, SK-131; 16) 96-2590, UDI/DI 50649111064577, Lot codes: FSF12, FSF17, FSF22; 17) 96-2591, UDI/DI 50649111064799, Lot codes: FSF12, FSF13, FSF20, FSF26; 18) 96-2591A, UDI/DI 50649111487826, Lot codes: SK-112; 19) 96-2594, UDI/DI 50649111065437, Lot codes: FSF7, FSF12, FSF16, FSF17, FSF18; 20) 96-2595, UDI/DI 50649111065642, Lot codes: FSF5, FSF16, FSF18, FSF19, FSF20; 21) 96-2595A, UDI/DI 50649111488052, Lot codes: SK-112; 22) 96-2599, UDI/DI 50649111066342, Lot codes: FSF6, FSF21; 23) 96-2659, UDI/DI 50649111077669, Lot codes: SK-130; 24) 96-2710, UDI/DI 50649111085664, Lot codes: FSF13; 25) 96-2711, UDI/DI 50649111478886, Lot codes: FSF10; 26) 96-2711A, UDI/DI 50649111488069, Lot codes: SK-112; 27) 96-2712, UDI/DI 50649111085916, Lot codes: FSF10; 28) 96-2740A, UDI/DI 50649111488274, Lot codes: SK-112; 29) 96-2741A, UDI/DI 50649111488281, Lot codes: SK-112; 30) 96-2742A, UDI/DI 50649111488298, Lot codes: SK-112; 31) 96-2745A, UDI/DI 50649111487949, Lot codes: 60440.

Distribution pattern

Domestic: Nationwide Distribution