Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,910 total recalls
- #1 of 12 among categories
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 recalls
- FDA Food 35
FDA Food
35 recalls
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 381 of 819
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
Zimmer Biomet, Inc.
Prismaflex Control Unit, software versions below 7.21
Baxter Healthcare Corporation
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263…
Zimmer Biomet, Inc.
Autoject EI, REF AJ1310
Owen Mumford USA, Inc.
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments…
Zimmer Biomet, Inc.
Prismaflex Control Unit, software versions below 7.21
Baxter Healthcare Corporation
VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-laye…
Ortho-Clinical Diagnostics
(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and …
Argon Medical Devices, Inc
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530 00118100532 00118100535 00118100537 00118100540 001181…
Zimmer Biomet, Inc.
PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 472358…
Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 002240…
Zimmer Biomet, Inc.
VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
Ortho-Clinical Diagnostics
LPS-MOB ART SURF IMPL D 9MM
Zimmer Biomet, Inc.
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external program…
LivaNova USA Inc
Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589…
Datascope Corp.
ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00…
Zimmer Biomet, Inc.
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide …
Western / Scott Fetzer Company
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, …
Argon Medical Devices, Inc
Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 …
Zimmer Biomet, Inc.
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 0052200…
Zimmer Biomet, Inc.
Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 0023…
Zimmer Biomet, Inc.
Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide …
Western / Scott Fetzer Company
NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107
Zimmer Biomet, Inc.
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Pega Medical Inc.
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Insulet Corporation
DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 4…
Zimmer Biomet, Inc.
Prismaflex Control Unit, software versions below 7.21
Baxter Healthcare Corporation
Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 4724…
Zimmer Biomet, Inc.
Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955
Centurion Medical Products Corporation
Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 0…
Zimmer Biomet, Inc.
PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 0023480…
Zimmer Biomet, Inc.
NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
Zimmer Biomet, Inc.
Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905
Thermo Fisher Scientific (Monterrey)
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the ot…
GE Healthcare, LLC
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Zimmer Biomet, Inc.
cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Zimmer Biomet, Inc.
Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide …
Western / Scott Fetzer Company
Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Argon Medical Devices, Inc
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 010029611…
Zimmer Biomet, Inc.
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed i…
Argon Medical Devices, Inc
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are …
MEDTECH SAS
CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202
Zimmer Biomet, Inc.
13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a…
Becton Dickinson & Company
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Thermo Fisher Scientific (Monterrey)
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
Ortho-Clinical Diagnostics
Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide …
Western / Scott Fetzer Company
Petfine Auto Injector, REF 3310VET
Owen Mumford USA, Inc.
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIF…
Helena Laboratories, Corp.
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes wi…
Philips Medical Systems (Cleveland) Inc
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices - browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jul 29, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jul 29, 2026.