Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1826–1850 of 2228

HighFDA (Devices)·Z-1236-2015·2015-03-11
Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices
Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.
Product
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1226-2015·2015-03-11
Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns
Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.
Product
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical En
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1133-2015·2015-03-04
Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise
Zimmer GmbH is recalling 30 Metasul Femoral Head units due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
Product
Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-1135-2105·2015-03-04
Zimmer CoCr Femoral Heads Recalled for Potential Sterile Tray Compromise
Zimmer GmbH is recalling 6,109 CoCr femoral heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
Product
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-1136-2015·2015-03-04
Zimmer Metasul Femoral Head Recalled for Potential Sterile Tray Compromise
Zimmer GmbH is recalling 16 Metasul Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection if undetected.
Product
Metasul Femoral Head - indicated for total hip arthroplasty for treatment of patient conditions of non-inflammatory degenerative joint disease.
Category
Medical Device
Distribution
45 states
ModerateFDA (Drugs)·D-0380-2015·2015-02-04
Baxter Recalls Fluconazole Injection Bags Due to Seal Defects
Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise sterility.
Product
FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0334-2015·2015-01-14
Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.
Product
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2015·2015-01-07
Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise
Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.
Product
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmia
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0861-2015·2014-12-31
US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues
US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.
Product
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0805-2015·2014-12-24
AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns
American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.
Product
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting o
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0295-2015·2014-12-17
Fresenius Kabi Recalls Midazolam Hydrochloride Injection Vials Due to Sterility Concerns
Fresenius Kabi USA is recalling 101,200 vials of Midazolam Hydrochloride Injection due to potential glass fractures and particles that compromise sterility.
Product
MIDAZOLAM — MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0297-2015·2014-12-17
Fresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns
Fresenius Kabi USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.
Product
CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0383-2015·2014-12-10
Customed Minor Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0406-2015·2014-12-10
Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0359-2015·2014-12-10
Customed Debridement Tray Recalled Due to Sterility Compromise
Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0342-2015·2014-12-10
Customed Cystoscopy Pack III Recalled for Sterility Compromise
Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0314-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.
Product
Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0413-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 372 Laparotomy Packs (Catalog # 900-996) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0377-2015·2014-12-10
Customed Cesarean Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0399-2015·2014-12-10
Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise
Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0316-2015·2014-12-10
Customed Laparoscopy Premium Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0319-2015·2014-12-10
Customed Ophthalmic Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0362-2015·2014-12-10
Customed Laparotomy Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 852 Laparotomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0354-2015·2014-12-10
Customed Extremity PACK Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 168 Extremity PACKs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0356-2015·2014-12-10
Customed Open Heart Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 106 Open Heart Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Open Heart Pack, catalog #900-2618 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states