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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77717

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

Open FDA event record

Event summary

Timeline bucket
June 30, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sorin Group USA, Inc.

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

6 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 6

STOCKERT Heater-Cooler System 3T, 230 V

Z-2771-2017
Recall number
Z-2771-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-83; Serial No. 16S11455-16S16509

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

device · product 2 of 6

STOCKERT Heater-Cooler System 3T, 240V/60 Hz

Z-2772-2017
Recall number
Z-2772-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-81; Serial No. 16S10743-16S11708

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

device · product 3 of 6

STOCKERT Heater-Cooler System 3T, 208V/60 Hz

Z-2773-2017
Recall number
Z-2773-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-82; Serial No. 16S10772-16S16840

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

device · product 4 of 6

STOCKERT Heater-Cooler System 3T, 127V/60 Hz

Z-2774-2017
Recall number
Z-2774-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-83; Serial No. 16S11455-16S16509

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

device · product 5 of 6

STOCKERT Heater-Cooler System 3T, 120V/60 Hz

Z-2775-2017
Recall number
Z-2775-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-85; Serial No. 16S10958-16S16847

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

device · product 6 of 6

STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

Z-2776-2017
Recall number
Z-2776-2017
Initiated
June 30, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
7,546 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

Code information

Item No. 16-02-85; Serial No. 16S10958-16S16847

Distribution pattern

"Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."