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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 8 of 3462

Product Firm Event Initiated
CRE Pro Wireguided 15-18mm 240cm Boston Scientific Corporation Event 99067 May 21, 2026
CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used. Bard Access Systems, Inc. Event 99096 May 21, 2026
Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK Medline Industries, LP Event 99162 May 21, 2026
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108754 P4154108D PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108761 The PowerMidline" Catheter is intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Bard Access Systems, Inc. Event 99096 May 21, 2026
CRE Pro Wireguided 6-8mm 240cm Boston Scientific Corporation Event 99067 May 21, 2026
CRE Wireguided 8-10mm 240cm Boston Scientific Corporation Event 99067 May 21, 2026
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein. Bard Access Systems, Inc. Event 99096 May 21, 2026
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 Medline Industries, LP Event 99162 May 21, 2026
CRE Pro Wireguided 12-15mm 240cm Boston Scientific Corporation Event 99067 May 21, 2026
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I Medline Industries, LP Event 99162 May 21, 2026
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153952 S4153108DCP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741233258 S4153108DGP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154027 S4254108BD Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154140 S4254108BDP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154164 S4254108D Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154119 S4254108DCP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741233234 S4254108DGP Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154188 SP4153108D Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185052 SP4153108DG Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741185069 The Provena" Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media. Bard Access Systems, Inc. Event 99096 May 21, 2026
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. Bard Access Systems, Inc. Event 99096 May 21, 2026
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL LINE KIT, Model Number: CVI4880B; 3) 20G x 6" ARTERIAL CATHETER KIT, Model Number: ART356; 4) MULTIMED 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC03; 5) A-LINE KIT, NO CATH, Model Number: ARTNC217; 6) PRESSURE INJ. CVC INSERTION BUNDLE, Model Number: ECVC1720; 7) DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4815; 8) MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: STCVC04; 9) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 10) ARTERIAL LINE TRAY, Model Number: ART350; 11) CVC INSERTION BUNDLE 8.5FR 4L 16CM, Model Number: ECVC6355; 12) UMBILICAL VESSEL INSERTION TRAY, Model Number: UVT980; 13) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; 14) UCLA - FINE NEEDLE BIOPSY, Model Number: P972300A; 15) TRIPLE LUMEN COMPLETE CATH KIT 16CM, Model Number: ECVC825A; 16) 8.5F 4L 20CM CVC + BUNDLE, Model Number: ECVC8640; 17) ULTRA CORE BIOPSY KIT, Model Number: SPEC0291B; 18) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number: ECVC7605; 19) WATERBURY 3L CVC BUNDLE, Model Number: ECVC7330; 20) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; 21) VANTEX 8.5FR 2L 16CM CVC BUNDLE-US, Model Number: ECVC8110; 22) FEMORAL ARTERIAL LINE TRAY, Model Number: ART660A; 23) VANTEX 3L, 7FR, 16CM CVC INSERTION BNDL, Model Number: ECVC5370B; 24) STD, VAN, 3L, 7F, 20CM, KIC, Model Number: A3720KIC; 25) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 26) VANTEX 7FR 3L 20CM CVC BUNDLE W/US, Model Number: ECVC8180; 27) NO CATH DIALYSIS KIT, Model Number: ECVC8595; 28) SOFT TISSUE TRAY, Model Number: DYNDA1954A; 30) LACERATION TRAY WITH LIDOCAINE, Model Number: SUT10830A; 31) LACERATION TRAY, Model Number: SUT10520; 32) VANTEX 7F 20CM 3L CVC BUNDLE, Model Number: CMPV7203LBB; 33) VANTEX 7F 16CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8380B; 34) BIOPSY TRAY, Model Number: MNS7065A; 35) STD, INTRO-FLEX INTRODUCER 8.5F, Model Number: I500BF85; 36) A LINE TRAY, Model Number: ART690; 37) 8.5F 16cm DOUBLE LUMEN CVC BUNDLE, Model Number: ECVC5490; 38) VANTEX 8.5FR 16CM 4L CVC BUNDLE, Model Number: ECVC8633; 39) VANTEX PI CVC 7F, 3L, 16CM BUNDLE, Model Number: ECVC6920A; 40) BIOPSY PACK, Model Number: DYNDH1135B; 41) PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; 42) VANTEX 7F 16CM 3L PI CVC BUNDLE, Model Number: ECVC7485; 43) ULTRA SOUND TRAY, Model Number: CVI190; 44) BASIC BIOPSY TRAY, Model Number: SPEC0051; 45) MULTIMED 7F 20CM 3L CVC BUNDLE, Model Number: CMPM7203LBB; 46) TRIPLE LUMEN CVC INSERTION TRAY, Model Number: ECVC1490A; 47) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; 48) LOCAL INFILTRATION TRAY, Model Number: DYNDH1406; 49) VANTEX 7FR 20CM 3L CVC BUNDLE, Model Number: ECVC8632; 50) I & D KIT, Model Number: ID1135A; 51) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC8637; 52) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number: ECVC5080; 53) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; 54) VASCULAR ACCESS INSERTION KIT, Model Number: CVI5331; 55) VANTEX 7F 20CM 3L CVC BUNDLE PLUS, Model Number: CMPV7203LBPA; 56) VANTEX 7FR 3L 20CM BUNDLE, Model Number: ECVC6110B; 57) A LINE KIT, 20G, Model Number: ART1303; 58) DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; 59) 7FR 3L 20CM CVC INSERTION BNDL, Model Number: ECVC7830C; 60) CVC INSERTION KIT 3L-16CM, Model Number: ECVC8616; 61) VANTEX 7FR 3L 20CM CVC BUNDLE US, Model Number: ECVC8320A; 62) VANTEX 7F 20CM TRIPLE LUMEN CVC KIT, Model Number: ECVC8385B; 63) TRIPLE LUMEN BUNDLE, Model Number: ECVC5475; 64) CVC BUNDLE KIT, Model Number: ECVC1700; 65) 3" 20G RADIAL ARTERIAL LINE KIT-ICU, Model Number: ART240C; 66) MAXIMUM PROTECTION CVC INSERTION KIT, Model Number: ECVC1950; 67) CVC TRIPLE LUMEN 7FR PI 16CM BUNDLE, Model Number: ECVC8360; 68) PLASTICS SUTURING SET, Model Number: SUT4065; 69) 3L 7F 20CM CVC INSERTION KIT, Model Number: ECVC8465; 70) ARTHROGRAM TRAY, M Medline Industries, LP Event 99162 May 21, 2026
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling. Bard Access Systems, Inc. Event 99096 May 21, 2026
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147 Medline Industries, LP Event 99162 May 21, 2026
CRE Pro Wireguided 10-12mm 240cm Boston Scientific Corporation Event 99067 May 21, 2026
Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C Medline Industries, LP Event 99162 May 21, 2026
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P155615A; 6) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 7) LACERATION TRAY, Model Number: SUT18660A; 8) GENERAL BIOPSY TRAY, Model Number: MNS5985; 9) LACERATION TRAY, Model Number: DYNDL1351; 10) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 11) ARTERIAL LINE TRAY, Model Number: ART600; 12) SUTURE TRAY, Model Number: SUT12260; 13) ER SUTURING TRAY, Model Number: SUT9710C; 14) INCISION & DRAINAGE TRAY, Model Number: ID2060; 15) LACERATION TRAY - SNAG FREE, Model Number: SUT12265; 16) BIOPSY TRAY, Model Number: DYNDH1466; 17) GENERAL BIOPSY TRAY, Model Number: MNS5985; 18) SUTURE SET, Model Number: SUT19665; 19) MYELOGRAM-LF SAFE PACK, Model Number: P124863; 20) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 21) LACERATION TRAY, Model Number: SUT18660A; 22) 20GX6" FEMORAL ART LINE KIT, Model Number: ART352; 23) BIOPSY PACK, Model Number: DYNDH1699; 24) SUTURE TRAY, Model Number: SUT12260; 25) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 26) ARTHROGRAM TRAY, Model Number: SPEC0070B; 27) SUTURING SET, Model Number: SUT4155; 28) SUTURE TRAY, Model Number: SUT16080; 30) MYELOGRAM TRAY CHOICE, Model Number: DYNDH1213; 31) MYELOGRAM PACK, Model Number: P155615A; 32) LACERATION TRAY - SNAG FREE, Model Number: SUT12265 Medline Industries, LP Event 99162 May 21, 2026
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media. Bard Access Systems, Inc. Event 99096 May 21, 2026
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 Keystone Industries Event 99076 May 21, 2026
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. Keystone Industries Event 99076 May 21, 2026
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. Keystone Industries Event 99076 May 21, 2026
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 Keystone Industries Event 99076 May 21, 2026
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. Keystone Industries Event 99076 May 21, 2026
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 Keystone Industries Event 99076 May 21, 2026