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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
Nov 24, 2025 BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Removal of affected lot of screws due to labeling error. Class II Smith & Nephew, Inc.
Mar 18, 2025 META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be unde... Class II Smith & Nephew, Inc.
Oct 15, 2024 Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I... The Bipolar assembly contains an oversized Retainer Ring. Class II Smith & Nephew, Inc.
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Jul 9, 2024 DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires d... Class II Smith & Nephew, Inc.
Sep 27, 2023 JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, Inc.
Sep 27, 2023 JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... Class II Smith & Nephew, Inc.
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... Class II Smith & Nephew, Inc.
Jul 24, 2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71... A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL... Class II Smith & Nephew, Inc.
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Par... Recent complaint data indicates that the revision rate may be trending higher than corresponding ... Class II Smith & Nephew, Inc.
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part ... Recent complaint data indicates that the revision rate may be trending higher than corresponding ... Class II Smith & Nephew, Inc.
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components... Recent complaint data indicates that the revision rate may be trending higher than corresponding ... Class II Smith & Nephew, Inc.
May 2, 2023 Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part ... Recent complaint data indicates that the revision rate may be trending higher than corresponding ... Class II Smith & Nephew, Inc.
Mar 27, 2023 JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box incorrectly containing ... Class II Smith & Nephew, Inc.
Jun 27, 2022 (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. ... The product was mispackaged (swapped). The devices within the inner tray matches the inner tray ... Class II Smith & Nephew, Inc.
Jan 4, 2022 INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw Class II Smith & Nephew, Inc.
Dec 14, 2021 Acufex Access Advanced Positioning Kit - indicated for use to position and di... Products were shipped to the Global Distribution Center instead of the sterilizer and therefore p... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Nov 1, 2021 smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponent... Class II Smith & Nephew, Inc.
Oct 25, 2021 Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM... The labels on the packages of screws were switched. Class II Smith & Nephew, Inc.
Sep 20, 2021 6.5MMX165MM CANNULATED SCREW The product label incorrectly indicated that the screws are fully threaded, but the screws contai... Class II Smith & Nephew, Inc.
May 19, 2021 LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, ... The device components experienced a manufacturing process error that resulted in surface damage f... Class II Smith & Nephew, Inc.
Apr 8, 2021 CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class II Smith & Nephew, Inc.
Dec 18, 2020 VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product ... Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grai... Class II Smith & Nephew, Inc.
Nov 2, 2020 Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures ... Manufacturing packaging error. Class II Smith & Nephew, Inc.
Sep 21, 2020 Genesis (GII) - Product Usage: designed for use in patients in primary and re... The anterior locking detail does not meet its design specifications. Class II Smith & Nephew, Inc.
Sep 21, 2020 5.5MM Arthrogarde Hip Access Cannula The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from ... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 4.5 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 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 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- 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 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N... 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 6.5MM PLLA/HA 2 UBWHT/BL-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 ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... 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 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 TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... 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 ULTRA-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 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... 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 / 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 TWINFIX 6.5MM AB PRELOADED ULTRABRAID- 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 RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-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 TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--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 HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N... 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 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 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/ 1 UB COBRAID 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 HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- 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 TWINFIX ULTRA PLLA HA 6.5MM 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 BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 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 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... 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.