Browse Device Recalls
2,560 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,560 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 2,560 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 16, 2015 | MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; T... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM M... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 16, 2015 | Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6... | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains i... | Class III | Biomet, Inc. |
| Apr 13, 2015 | Elastic Knee Support. A limb orthosis (brace) is a device intended for med... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 13, 2015 | Elastic Ankle Support. A limb orthosis (brace) is a device intended for me... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 13, 2015 | Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) ... | The product does not bear the caution label regarding latex content. Potential for Allergic skin... | Class II | United Surgical Associates |
| Apr 7, 2015 | HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter... | HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as con... | Class II | Catheter Research, Inc |
| Apr 2, 2015 | NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Int... | The affected lot is being recalled because it was packaged without the locking screw. The lockin... | Class II | Zimmer, Inc. |
| Mar 23, 2015 | Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 1... | Customers complained about under-recovery of non-Roche controls and discrepant low patient result... | Class II | Roche Diagnostics Operations, Inc. |
| Mar 20, 2015 | Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift. | Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If t... | Class II | Hill-Rom, Inc. |
| Mar 18, 2015 | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Pro... | A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number... | Class II | Biomet, Inc. |
| Mar 10, 2015 | Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Person... | Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking ... | Class II | Zimmer, Inc. |
| Mar 4, 2015 | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prost... | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... | Class II | DePuy Orthopaedics, Inc. |
| Mar 4, 2015 | LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthop... | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... | Class II | DePuy Orthopaedics, Inc. |
| Mar 2, 2015 | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. | The metal cannula attached to the handpiece can rotate and become dislodged from the plastic hand... | Class II | Hill-Rom, Inc. |
| Feb 26, 2015 | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligame... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, Inc. |
| Feb 26, 2015 | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable syst... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, Inc. |
| Feb 23, 2015 | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instru... | This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery... | Class II | DePuy Orthopaedics, Inc. |
| Feb 17, 2015 | Double Swivel Connector with Suction Port Connector, Airway (Extension) Kin... | Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel ... | Class II | King Systems Corp. |
| Feb 11, 2015 | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl m... | One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in sur... | Class II | DePuy Orthopaedics, Inc. |
| Feb 5, 2015 | Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem ... | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. | Class II | Zimmer, Inc. |
| Jan 28, 2015 | Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Pa... | An increase in complaints of loosening and radiolucent lines. | Class II | Zimmer, Inc. |
| Jan 9, 2015 | Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... | Class II | Biomet, Inc. |
| Jan 9, 2015 | Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis co... | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetab... | Class II | Biomet, Inc. |
| Jan 7, 2015 | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Ada... | The taper adaptor is missing from the packaging, which may result in a delay in surgery greater t... | Class II | Biomet, Inc. |
| Dec 18, 2014 | Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer | Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positi... | Class II | Roche Diagnostics Operations, Inc. |
| Dec 11, 2014 | Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots ... | Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of s... | Class II | Zimmer, Inc. |
| Dec 8, 2014 | Osteobond Bone Cement Bone cement monomer is kitted with bone cement powde... | Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between ... | Class II | Zimmer, Inc. |
| Dec 4, 2014 | Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Ti... | The affected lot was supplied by contract manufacturer and are potentially subject to disassociat... | Class II | Zimmer, Inc. |
| Dec 2, 2014 | Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... | Class II | Biomet, Inc. |
| Dec 2, 2014 | Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... | After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... | Class II | Biomet, Inc. |
| Nov 25, 2014 | Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... | Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... | Class II | Zimmer, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the ... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infus... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusi... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the ... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infus... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the ... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for t... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusi... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the ... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusi... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 20, 2014 | ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the... | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 12, 2014 | I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. ... | Use of excessive force when impacting may lead to intra-operative femoral fracture. | Class II | DePuy Orthopaedics, Inc. |
| Nov 10, 2014 | Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors a... | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... | Class II | DePuy Orthopaedics, Inc. |
| Nov 10, 2014 | The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in ... | Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during i... | Class II | DePuy Orthopaedics, Inc. |
| Nov 10, 2014 | Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Imp... | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... | Class II | DePuy Orthopaedics, Inc. |
| Nov 10, 2014 | Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactor... | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produc... | Class II | DePuy Orthopaedics, 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.