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.

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DateProductReasonClassFirm
Jul 17, 2012 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 17, 2012 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of product... BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length c... Class II Nico Corp.
Jul 13, 2012 The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-ste... Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NC... Class II Zimmer, Inc.
Jun 18, 2012 Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity pa... During an evaluation of Advanta 2 siderail samples returned from the field it was found that the ... Class II Hill-Rom, Inc.
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class II OrthoPediatrics Corp
Jun 5, 2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrume... Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle hand... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight h... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
May 16, 2012 LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 10 Packaging: The product was packaged within inner and oute... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer b... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 15, 2012 PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are i... During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was ... Class II Polymer Technology Systems, Inc.
May 12, 2012 Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instr... Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Sto... Class II Zimmer, Inc.
Apr 30, 2012 Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provi... The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of ... Class II Zimmer Inc.
Apr 30, 2012 Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, R... The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of ... Class II Zimmer Inc.
Apr 19, 2012 ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... Potential failure of the optical distance sensor due to cable disconnection. Class II Zimmer Biomet, Inc.
Apr 2, 2012 Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birth... During review of our last braking system via that field corrective action, the system still did n... Class II Hill-Rom, Inc.
Mar 7, 2012 Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 ... DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner be... Class II DePuy Orthopaedics, Inc.
Sep 12, 2011 Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in ... The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the lab... Class I Engineered Medical Systems,Inc
Apr 1, 2011 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femor... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Oct 10, 2010 . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys F... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 Ver... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... 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.