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Browse Device Recalls

278 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 278 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 278 FDA device recalls.

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DateProductReasonClassFirm
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Aug 24, 2020 EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indic... Multiple or incorrect expiration dates were provided on the affected designation labels. Class II Smith & Nephew, Inc.
Aug 3, 2020 Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during sur... The products were improperly heat treated. Class II Smith & Nephew, Inc.
Jul 16, 2020 Tibial knee prosthesis Due to an inconsistency in the raw material process, specific lots may contain units with interna... Class II Smith & Nephew, Inc.
Jun 29, 2020 PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usa... The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part. Class II Smith & Nephew, Inc.
Jun 24, 2020 Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage... The T-Fix sterile package contains only one sleeve instead of two, The device will not perform a... Class II Smith & Nephew, Inc.
Jun 24, 2020 SUTUREFIX ULTRA Suture, Product number 72203855 A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL d... Class II Smith & Nephew, Inc.
Jun 24, 2020 TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistanc... A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight p... Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manu... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Mar 17, 2020 Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901 Space between the device and the packaging permits excessive movement which could potentially lea... Class II Smith & Nephew, Inc.
Mar 17, 2020 Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 Space between the device and the packaging permits excessive movement which could potentially lea... Class II Smith & Nephew, Inc.
Feb 27, 2020 NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissu... Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraopera... Class II Smith & Nephew, Inc.
Jan 28, 2020 JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usa... The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... Class II Smith & Nephew, Inc.
Jan 28, 2020 JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usa... The spike rail was manufactured with an oversized thru-hole which could potentially cause the dow... Class II Smith & Nephew, Inc.
Dec 30, 2019 TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende... Due to a potential for sterile barrier breach. A complaint was received that indicated the protec... Class II Smith & Nephew, Inc.
Dec 19, 2019 LEGION PS High Flex XLPE size 5-6 9mm Articular Insert LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part Class II Smith & Nephew, Inc.
Dec 16, 2019 LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6... Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunge... Class II Smith & Nephew, Inc.
Nov 11, 2019 smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROF... There is a a potential failure mode associated with the use of the mallet, wherein the poly tip o... Class II Smith & Nephew, Inc.
Oct 7, 2019 LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product Usage: The TRIGEN In... LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls ... Class II Smith & Nephew, Inc.
Feb 19, 2019 smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 ... Complaints were received indicating that the outer label incorrectly identified the product as si... Class II Smith & Nephew, Inc.
Feb 19, 2019 smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZ... Complaints were received indicating that the outer label incorrectly identified the product as si... Class II Smith & Nephew, Inc.
Jan 7, 2019 SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613 The pin that holds the spring mechanism is not properly mounted. The pin could potentially disass... Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2 , REF 74013986 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Dec 10, 2018 JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNE... Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch Class II Smith & Nephew, Inc.
Sep 18, 2018 Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 RE... One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. Class II Smith & Nephew, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.