Browse Device Recalls

2,549 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,549 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 2,549 FDA device recalls in IN.

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DateProductReasonClassFirm
Jul 22, 2014 Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FN... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 4.5 mm Malleolar Screw Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 17, 2014 Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Denta... Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8m... Class II Zimmer, Inc.
Jul 17, 2014 CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... This remedial action is the result of six product complaints associated with separation of the sn... Class I Cook Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part N... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 1, 2014 Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... Class II Biomet, Inc.
Jul 1, 2014 Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 2... Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenest... Class II Zimmer, Inc.
Jul 1, 2014 PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... Class II Zimmer, Inc.
Jul 1, 2014 PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... Class II Zimmer, Inc.
Jun 26, 2014 Esaote PA230E Transducer A portable and cart base ultrasound system for gene... Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D... Class II Biosound Esaote, Inc.
Jun 26, 2014 Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be us... The attachment latch mechanism can become bent depending on user handling. Latch mechanism bendi... Class II Hill-Rom, Inc.
Jun 25, 2014 Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer, Inc.
Jun 23, 2014 Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... Class II Biomet, Inc.
Jun 10, 2014 Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral C... A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an e... Class II Zimmer, Inc.
Jun 4, 2014 ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... Software corrections reactivating the cooperative endoscopy mode. Class II Zimmer Biomet, Inc.
Jun 3, 2014 RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. R... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manua... The product can be difficult to remove from the Distal Stem both out of the package and after pr... Class II DePuy Orthopaedics, Inc.
Jun 3, 2014 RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sl... The product can be difficult to remove from the Distal Stem both out of the package and after pro... Class II DePuy Orthopaedics, Inc.
May 23, 2014 Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, ... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 21, 2014 cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 21, 2014 cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 21, 2014 Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... Class II Roche Diagnostics Operations, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
May 15, 2014 DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT T... Surface finish is different than specified. The implant has 30 grit blast on the exterior of the... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument fo... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
May 7, 2014 G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument f... Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter o... Class II Biomet, Inc.
Apr 23, 2014 Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 med... The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the ... Class II Heraeus Kulzer, LLC.
Apr 22, 2014 ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesi... This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge r... Class II Biomet, Inc.
Apr 18, 2014 RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ..... All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have ... Class II Med-Mizer, Inc.
Apr 18, 2014 RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803,... All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have... Class II Med-Mizer, Inc.
Apr 18, 2014 RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed... All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have ... Class II Med-Mizer, Inc.
Apr 15, 2014 EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthope... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunc... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 15, 2014 EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manu... The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked mak... Class II Biomet, Inc.
Apr 14, 2014 ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Mete... Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneous... Class II Roche Diagnostics Operations, 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.