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Browse Device Recalls

135 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 135 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 135 FDA device recalls.

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DateProductReasonClassFirm
Jan 11, 2016 Product 16 consists of all product under poduct code: KWY and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 4 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 43 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 42 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 56 consists of all product under product code: HWC and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 15 consists of all product code JDI , and same usage: Item no: 80... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 3 consists of all products under product code JDI, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 8 consists of all products under product code HWC, and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 7 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 27 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 37 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 64 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 1 consists of all product under , product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 54 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 67 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 35 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 19 consists of all product code: JDI and same usage: Item no: 7653... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 62 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 14 consists of all product under product code HSB , and same usage:... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 65 consists of all product under product code: KTT and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 10consists of all product under product code HWC, and same usage: It... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 59 consists of all product under product code: JWH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 34 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 45 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 17 consists of all product under product code: LPH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 36 consists of all product under product code: HSB and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 51 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 28 consists of all product under product code: JDI and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 5 consists of all products under product code HWC, and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 18 consists of all product under product code: HWC and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 52 consists of product code: HWC and same usage: Item no: 52500453... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 29 consists of all product under product code: LPHand same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 31 consists of all product under product code: KTT and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 12 consists of all product under product code JDI , and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 48 consists of all product under product code: JWH and same usage: ... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 11, 2016 Product 25 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Dec 3, 2015 NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and RE... A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 ... Class II Zimmer Manufacturing B.V.
Dec 2, 2015 Label reading in part as: "NexGen System, Complete Knee Solution; Reference N... Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th... Class II Zimmer Manufacturing B.V.
Dec 4, 2014 Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular... Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell... Class II Zimmer Manufacturing B.V.
Nov 21, 2014 Bone Screw, self-tapping The Trilogy shells are available in three configura... Analysis of returned complaint devices, product in inventory, and device manufacturing records ha... Class II Zimmer Manufacturing B.V.
Jun 12, 2014 Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREA... Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 we... Class II Zimmer Manufacturing B.V.
Oct 11, 2013 PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 4... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LA... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE L... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FEM HD ION (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM a... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, 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.